File(s) under embargo
until file(s) become available
Patient-specific devices and population-level evidence: evaluating therapeutic interventions with inherent variation
journal contributionposted on 08.01.2021, 04:29 by Mary Walker
© 2017, Springer Science+Business Media B.V. Designing and manufacturing medical devices for specific patients is becoming increasingly feasible with developments in 3D printing and 3D imaging software. This raises the question of how patient-specific devices can be evaluated, since our ‘gold standard’ method for evaluation, the randomised controlled trial (RCT), requires that an intervention is standardised across a number of individuals in an experimental group. I distinguish several senses of patient-specific device, and focus the discussion on understanding the problem of variations between instances of an intervention for RCT evaluation. I argue that, despite initial appearances, it is theoretically possible to use RCTs to evaluate some patient-specific medical devices. However, the argument reveals significant difficulties for ensuring the validity of such trials, with implications for how we should think about methods of evidence gathering and regulatory approaches for these technologies.
My thanks to Robert Sparrow, Wendy Rogers, David Wotton, Tajanka Mladenovska, and the anonymous referees for this journal, for their comments on previous drafts. The funding was provided by Australian Research Council (Grant No. CE140100012)
JournalMedicine, Health Care and Philosophy
Pagination11p. (p. 335-345)
Rights StatementThe Author reserves all moral rights over the deposited text and must be credited if any re-use occurs. Documents deposited in OPAL are the Open Access versions of outputs published elsewhere. Changes resulting from the publishing process may therefore not be reflected in this document. The final published version may be obtained via the publisher’s DOI. Please note that additional copyright and access restrictions may apply to the published version.
Social SciencesArts & HumanitiesEthicsHistory & Philosophy Of ScienceSocial Sciences - Other TopicsHistory & Philosophy of ScienceMedical deviceRegulationRandomised controlled trialPersonalised medicine3D printingRANDOMIZED CONTROLLED-TRIALSCOMPLEX INTERVENTIONSFEMORAL COMPONENTSRESISTANCEDESIGNMECHANISMSMEDICINEFIDELITYSURVIVALSURGERYHumansEquipment DesignEquipment and SuppliesResearch DesignRandomized Controlled Trials as TopicPrinting, Three-DimensionalPrecision MedicineApplied Ethics